Periset 8 mg Tablet: Each film-coated tablet contains Ondansetron Hydrochloride USP equivalent to Ondansetron 8 mg.
Periset 4 ml Injection: Each ml contains Ondansetron Hydrochloride USP equivalent to Ondansetron 2 mg.
Ondansetron is a highly selective 5-HT₃ receptor antagonist. 5-HT₃ serotonin receptors are present both peripherally on vagal nerve terminals and centrally in chemoreceptor trigger zone of the postrema. It is not certain whether ondansetron’s antiemetic action is mediated centrally, peripherally, or in both sites. However, cytotoxic chemotherapy appears to be associated with the release of serotonin from enterochromaffin cells of the small intestine.
Prevention of nausea-vomiting associated with chemotherapy:
Age Category.
Oral tablet.
Parenteral (IM/IV).
Adults/ Geriatric/Child of 12 years or over.
Highly emetogenic cancer chemotherapy: 24 mg (three 8 mg tablets) administered 30 minutes before the start of emetogenic chemotherapy.
Moderate emetogenic cancer chemotherapy: 8 mg (one 8 mg tablet) administered 30 minutes before start of emetogenic chemotherapy. A further 8 mg dose should be administered after 8 hours of the first dose. One 8 mg tablet should be administered twice a day (every 12 hours) for 1-2 days after completion of chemotherapy.
32 mg single dose infused over 15 minutes by diluting with 50 ml saline (5% Dextrose or 9% NaCl) 30 minutes before starting chemotherapy.
Alternative therapy: Three dose 0.15 mg/kg body weight. The first dose is infused over 15 minutes beginning 30 minutes before the starting chemotherapy. Subsequent doses (0.15 mg/kg) are administered 4 and 8 hours after the first dose of administration.
Pediatric:4-11 years: 4 mg tablet should be taken 30 minutes before the start of chemotherapy. The other 2 doses should be taken 4 and 8 hours after the first dose. Then 4 mg tablet should be administered 3 times a day (every 8 hours) for 1-2 days after completion of chemotherapy.
6 months onwards: Three dose of 0.15 mg/kg body weight. The first dose is infused over 15 minutes beginning 30 minutes before starting moderately to highly emetogenic chemotherapy. Subsequent doses (0.15 mg/kg) are administered 4 and 8 hours after the first dose of administration.
Prevention of nausea-vomiting associated with radiotherapy:
(Either Total Body irradiation, or Single High Dose Fraction or Daily Fractions to the Abdomen).
Age Category.
Oral tablet.
Adults/ Geriatric/Child of 12 years or over.
The recommended dose is 8 mg tablet thrice a day.
For total body irradiation: one 8 mg tablet should be administered 1 to 2 hours before each fraction of radiotherapy administered each day.
For single high-dose fraction radiotherapy to the abdomen: one 8 mg tablet should be administered 1 to 2 hours before radiotherapy, with subsequent doses every 8 hours after the first dose for 1 to 2 days after completion of radiotherapy.
For daily fractionated radiotherapy to the abdomen: one 8 mg tablet should be administered 1 to 2 hours before radiotherapy, with subsequent doses every 8 hours after the first dose for each day.
Prevention of post operative nausea & vomiting:
Age Category.
Oral tablet.
Parenteral (IM/IV).
Adults/ Geriatric/Child of 12 years or over.
16 mg (two 8 mg tablets) 1 hour before induction of anesthesia.
Undiluted 4 mg intravenously or intramuscularly immediately before induction of anesthesia.
The rate of administration should not be less than 30 seconds, preferably over 2 to 5 minutes.
Alternatively, the dose can be administered post-operatively if the patient experiences nausea and/or vomiting shortly after surgery.
Pediatric (1 month to 12 years).
Weighing less than 40 kg: 0.1 mg/kg body weight in a single dose.
Weighing more than 40 kg: 4 mg single dose.
The dose should be immediately before induction of anesthesia. The rate of administration should not be less than 30 seconds, preferably over 2 to 5 minutes.
Alternatively, the dose can be administered post-operatively if the patient experiences nausea and/or vomiting shortly after surgery.
OR AS DIRECTED BY THE PHYSICIAN.
There is no evidence that Ondansetron either induces or inhibits the metabolism of other drugs commonly coadministered with it. But Ondansetron (HCl) is known to interact with other drugs like Carbamazepine, Phenytoin, Rifampicin and Tramadol.
Overdosage:
There is no specific antidote for Ondansetron overdose. Hypertension (and faintness) occurred in a patient that took 48 mg of Ondansetron.
Pregnancy: Pregnancy category B.
Ondansetron is not a drug that stimulates gastric or intestinal peristalsis. It should not be used instead of nasogastric suction. The use of Ondansetron in patients following abdominal surgery or in patients with chemotherapy-induced nausea and vomiting may mask a progressive ileus and/or gastric distension.
Store in a cool & dry place, protected from light. Keep all medicines out of reach of children.